Senator Josh Hawley from Missouri has taken a significant step in the ongoing debate about the abortion pill mifepristone by introducing new legislation aimed at stripping its FDA approval. The bill, known as the Safeguarding Women from Chemical Abortion Act, emphasizes Hawley’s longstanding concerns about the drug’s safety. This legislative move builds on a prior proposal he introduced last year, which aimed to ban mifepristone altogether and give women the ability to sue its manufacturers.
In a statement to Fox News Digital, Hawley expressed his view that “the science is clear” regarding the dangers of mifepristone. He referred to the drug as “inherently dangerous to women and prone to abuse,” suggesting that large companies, like Danco Laboratories, profit excessively from its sale. Hawley’s latest bill would, if passed, withdraw FDA approval of the drug and formally classify the distribution of mifepristone for abortion as a violation of federal law.
The statistics surrounding mifepristone’s use are staggering. In 2023, approximately 63% of all abortions in the United States involved this medication, according to the Guttmacher Institute. That same organization estimated over one million clinician-provided abortions took place in 2024. These figures only encompass states without abortion restrictions and do not account for other forms of abortion that may occur outside regulated medical settings.
Hawley’s skepticism towards mifepristone isn’t recent. He initially brought his concerns to light last May by introducing another bill focused on requiring the FDA to implement stricter safeguards for the drug. This legislation sought to empower women who experienced complications from using mifepristone to sue telehealth providers and pharmacies. Support for his argument comes from research conducted by the Ethics and Public Policy Center, which found that the rate of side effects associated with mifepristone is significantly higher—22 times—than what the FDA-approved label indicates. The research highlighted disconcerting side effects, with over 10% of women reporting serious complications such as infection, hemorrhaging, or life-threatening events after using the drug.
Moreover, the Biden administration’s FDA had previously relaxed rules to allow the prescription of mifepristone through telehealth. This change meant that women could access the abortion pill without needing to visit a doctor in person, raising further concerns among critics like Hawley.
In a related context, the Supreme Court recently upheld the FDA’s decision to maintain access to mifepristone, dismissing a challenge from the Alliance for Hippocratic Medicine. The Court ruled that this group did not possess the necessary legal standing to contest the FDA’s approval, indicating that the broader merits of the drug were not debated in their decision.
Hawley’s correspondence with FDA Commissioner Marty Makary from last May reiterated the necessity for ongoing scrutiny of mifepristone’s safety. During Makary’s Senate confirmation hearing, he assured Hawley that he would assess all relevant data concerning the drug. Hawley stressed the need for the FDA to act in accordance with new evidence to restore critical safeguards, emphasizing that “the health and safety of American women depend on it.”
As the debate over mifepristone continues, Hawley’s proposed bill represents a crucial turn in the concerted effort by some lawmakers to reassess the regulation and distribution of abortion-related medications. The implications of this legislation could have a significant impact on women’s health and the pharmaceutical industry.
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